Monday, October 20, 2025 – Pre-Conference Workshop DayMonday, 20 October 2025 - JT (Japan Time, GMT+09:00)

Course Overview:

This workshop provides a comprehensive overview of the key principles and best practices for crafting an effective global regulatory strategy to accelerate product approvals and market entry. Participants will explore regional regulatory requirements, submission pathways, and strategies to overcome common challenges in bringing your innovation to market efficiently.

This interactive session will include case studies, group discussions, and practical exercises to help participants apply regulatory strategies to real-world scenarios. Ideal for regulatory affairs professionals, product developers, and market access teams seeking to enhance their strategic planning for global product launches.

By the end of this workshop, participants will:

• Understand the critical components of a global regulatory strategy and its impact on product launch timelines.
• Learn how to navigate regional regulatory frameworks (e.g., FDA, EMA, PMDA, NMPA) to optimize submission processes.
• Identify expedited pathways and leverage them for faster approvals with practical examples

Course Overview:
Japan’s biopharmaceutical manufacturing ecosystem offers unique opportunities for global innovators, but success depends on understanding how to navigate its cultural, operational, and regulatory nuances. In this workshop, Stefan Sandström draws on deep experience in the Japanese market to provide a practical roadmap for building and sustaining successful partnerships with Japanese CDMOs.

Key Topics Include:

• A comprehensive overview of the Japanese CDMO landscape and its evolving role in global biomanufacturing
• Strategies for identifying and selecting the right Japanese CDMO based on product type, capabilities, and company alignment
• Best practices for negotiation and collaboration, including cross-cultural considerations and expectation setting
• Guidance on execution, relationship management, and conflict resolution to ensure long-term partnership success